Randox recalls STFR CAL calibrators for Siemens Atellica CH analyzers due to atypical calibration curves causing non-numerical results. Affected lots may underestimate results by up to 30%.
A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the Math Error flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.
Randox is recalling specific calibrator kits for Siemens Atellica CH analyzers because they can cause non-numerical results in lab tests. This issue affects certain lots that may underestimate test results by up to 30%.
The calibrators produce calibration curves that are too linear for the logitlog calculation, causing non-numerical results. This issue is detected in the Atellica graphical view but can sometimes go unnoticed, leading to underestimated test results by up to 30%.
Lab users with Siemens Atellica CH analyzers using the affected calibrator lots (537725, 562696) may see inaccurate test results. Most users are laboratory technicians and clinical staff.
Check the calibrator lot numbers: 537725 or 562696. This affects Randox STFR CAL calibrators (TF10159 and TF10161) sold with Siemens Atellica CH analyzers.
Verify the lot numbers on the calibrator: 537725 or 562696.
Randox identified that certain calibrator lots produce calibration curves too linear for the logitlog calculation, causing non-numerical results in Siemens Atellica CH analyzers.
Results for STFR Level 1 with concentrations less than 1.7mg/L may be underestimated by up to 30%.
Only Siemens Atellica CH analyzers.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1423-2022 — Randox Randox Hello, I own a Randox that is covered by recall Z-1423-2022 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
